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AstraZeneca Gets Block on Apotex Pulmicort Copies

By Pharmaceutical Processing | May 21, 2009

LONDON (AP) — AstraZeneca PLC said Thursday that a U.S. court has granted its request for an injunction barring Canada’s Apotex Inc. from selling a generic version of its child asthma medication Pulmicort Respules. The District Court in New Jersey granted the ban until a patent infringement trial is held, for which a date has not yet been set. The U.S. Food and Drug Administration granted approval to Apotex for a generic version of the drug in March, leading AstraZeneca to start legal action. Patents covering the drug expire in 2018 with pediatric exclusivity extending to 2019. AstraZeneca said Thursday it has “full confidence in the strength of the intellectual property rights” protecting the product. U.S. sales of Pulmicort were $982 million in 2008. Pulmicort Respules accounted for around 90 percent of that total. AstraZeneca shares rose 0.7 percent to 2,653 pounds ($41.46) on the London Stock Exchange.

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